NCT03186391

Brief Summary

The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Feb 2014Dec 2030

Study Start

First participant enrolled

February 24, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

16.9 years

First QC Date

May 23, 2017

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1-min Post-exercise Ankle-Brachial Index (ABI)

    Post exercise pressures at 1 minute after the stop of walking on each ankle and arm.

    at 1 minute after the stop of walking

Secondary Outcomes (2)

  • 3-min Post-exercise Ankle-Brachial Index (ABI)

    at 3 minutes after the stop of walking

  • 5-min Post-exercise Ankle-Brachial Index (ABI)

    at 5 minutes after the stop of walking

Study Arms (1)

Patients with suspected PAD

Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging

Other: Data collected

Interventions

Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging

Patients with suspected PAD

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to our vascular unit with exercise limitation

You may qualify if:

  • All patients addressed in our vascular unit for exercise limitation

You may not qualify if:

  • Incapacity to walk on the treadmill.
  • A severe cardiopathy contraindicating a stress test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Universitaire

Rennes, 35033, France

RECRUITING

Related Publications (2)

  • Vannier C, Guezais A, Talbot M, Le Faucheur A, Mahe G. Relationship between exercise transcutaneous oxygen pressure measurements with constant and graded treadmill tests. Vasc Med. 2025 Dec;30(6):676-682. doi: 10.1177/1358863X251379810. Epub 2025 Nov 5.

  • Metairie A, Tollenaere Q, Laneelle D, Le Faucheur A, Le Pabic E, Omarjee L, Mahe G. Simplification of ankle-brachial-index measurement using Doppler-waveform classification in symptomatic patients suspected of lower extremity artery disease. Front Cardiovasc Med. 2022 Sep 9;9:941600. doi: 10.3389/fcvm.2022.941600. eCollection 2022.

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Routinely Collected Health Data

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Health Care SurveysHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsHealth Care Quality, Access, and Evaluation

Study Officials

  • Mahé Guillaume, MD-PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahé Guillaume, MD-PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 14, 2017

Study Start

February 24, 2014

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations